P-MUC1C-ALLO1 Allogeneic CAR-T Cells In The Treatment Of Subjects With Advanced Or Metastatic Solid Tumors

Study Overview

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-MUC1C-ALLO1 to determine a Recommended Phase 2 Dose (RP2D). P-MUC1C-ALLO1 is an allogeneic chimeric antigen receptor (CAR) T cell therapy designed to target cancer cells expressing Mucin1 cell surface associated C-Terminal (MUC1-C) antigen. Additional participants will be treated with P-MUC1C-ALLO1 at the determined RP2D. Following enrollment, subjects will be treated with P-MUC1C-ALLO1 and will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.

Breast Cancer
Ovarian Cancer
Non Small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
Renal Cell Carcinoma
Nasopharyngeal Cancer
Head and Neck Squamous Cell Carcinoma
Gastric Cancer

BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells
DRUG: Rimiducid

P-MUC1C-ALLO1-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-02-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-18
First Submitted that Met QC Criteria 2022-02-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-24
First Posted (ACTUAL) 2022-02-14	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A) * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.	BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. DRUG: Rimiducid Rimiducid (safety switch activator) may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B) * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.	BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. DRUG: Rimiducid Rimiducid (safety switch activator) may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C) * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D) * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.	BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. DRUG: Rimiducid Rimiducid (safety switch activator) may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1) * Single ascending A1 dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.	BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. DRUG: Rimiducid Rimiducid (safety switch activator) may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E) * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F) * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.	BIOLOGICAL: P-MUC1C-ALLO1 CAR-T cells P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C. DRUG: Rimiducid Rimiducid (safety switch activator) may be administered as indicated.
EXPERIMENTAL: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M) * Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.

Primary Outcome Measures	Measure Description	Time Frame
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1	Number of subjects with a dose limiting toxicity (DLT)	Baseline through Day 28
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1	Frequency and severity of adverse events	Baseline through 15 years
Evaluate the preliminary efficacy of P-MUC1C-ALLO1	According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)	Baseline through 15 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Males or females, Subjects ≥18 years with life expectancy >3 months
Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer
Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, and have measurable disease
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%
Must have adequate vital organ function within pre-determined parameters
Must have archived tumor tissue available or consent to a biopsy collection
Must be willing to practice birth control
Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration
Must have recovered from toxicities due to prior therapies

Has inadequate venous access
Has an active second malignancy (not disease free for at least 5 years) in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
Is pregnant or lactating
Has a history of or active autoimmune disease
Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy
Has an active systemic (viral, bacterial, or fungal) infection
Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia
Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
Has received anticancer medications within 2 weeks of the time of initiating lymphodepletion
Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study
Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study
Has known CNS metastases or symptomatic CNS involvement
Has a history of significant liver disease or active liver disease
Has a history of known genetic predisposition to HLH/MAS
Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Simon Heidegger, M.D., Lead Medical Director, Oncology, Genentech Research Early Development

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.

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